Events

Biosense PentaRay Catheters 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Biosense Webster Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    20076
  • 사례 시작날짜
    2016-04-22
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    Biosense webster is clarifying the contraindication language in the instructions for use (ifu) and product labelling for use of this catheter relative to patients with prosthetic valves. the current language in the ifu provides a precaution against use of the pentaray® catheter in patients with prosthetic valves under the contraindication section stating: "[the] use of this catheter may not be appropriate for use in patients with prosthetic valves." the update to the ifu is to clarify the contraindication statement to the following: "do not use pentaray® catheters in patients with prosthetic valves".
  • 조치
    Instructions for use to be updated

Device

Biosense PentaRay Catheters
  • 모델명 / 제조번호(시리얼번호)
    Model: D128201, D128202, D128203, D128204, D128205, D128206, D128207, D128208, D128209, D128210, D128211, D128212, Affected: all Lot numbers
  • Manufacturer
    Biosense Webster Inc

Manufacturer

Biosense Webster Inc